MAUDE Adverse Event Report: MEDTRONIC IRELAND ONYX FRONTIER; STENT, CORONARY, DRUG-ELUTING

Model Number	ONYXNG25038UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a stent deployment procedure involving one onyx frontier drug-eluting stent, a balloon burst occurred at an inflation pressure of 12 atm on the first inflation.The procedure was conducted in the mid-section of the left anterior descending (lad) artery, which had an 80% lesion stenosis, mild tortuosity, and moderate calcification.The lesion was pre-dilated, and no resistance or excessive force was encountered during device delivery.The device was inspected, and negative prep was performed without issues.The device did not pass through a previously deployed stent.The stent remains implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: as the balloon ruptured at 12 atm the stent was deployed.The lesion was pre-dilated with a non-medtronic balloon.The device was not moved or repositioned in the lesion while inflated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Image analysis: fluoroscopic and ivus images were provided from the account.The fluoroscopic images confirm pre-dilation in the lad, followed by de livery of a stent to the mid to distal lad.Initial pressurization of the balloon deployed the stent.But further pressurization showed that the distal inflation lumen of the delivery system has expanded with the pressurization of the balloon.The contrast in the distal end of the balloon appears to flow backwards thus appearing as if the balloon has burst.There is no evidence of a burst of the balloon or shaft.The distal inflation lumen appears to have been damaged/necked resulting in expansion of the outer shaft when pressurized.It is possible that the distal inflation lumen burst, but this was not captured on the images provided.The images do not show when or why the distal shaft was damaged.Therefore, the root cause of the initiating factor for the alleged burst cannot be determined from the images.Product analysis: a visual inspection of the returned device found that the inflation lumen was stretched and had ruptured.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: annex d code.Correction: annex c code.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ONYX FRONTIER
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21696040
• Report Number: 9612164-2025-01534
• Device Sequence Number: 12974142
• Product Code: NIQ
• UDI-Device Identifier: 00763000511357
• UDI-Public: (01)00763000511357(17)260907(10)0011945812(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2026
• Device Model Number: ONYXNG25038UX
• Device Catalogue Number: ONYXNG25038UX
• Device Lot Number: 0011945812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 05/20/2025; 07/09/2025; 08/14/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/15/2025; 05/23/2025; 08/05/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG